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WO1999030644A1 - Introducteur d'implant corneen - Google Patents

Introducteur d'implant corneen Download PDF

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Publication number
WO1999030644A1
WO1999030644A1 PCT/US1998/027099 US9827099W WO9930644A1 WO 1999030644 A1 WO1999030644 A1 WO 1999030644A1 US 9827099 W US9827099 W US 9827099W WO 9930644 A1 WO9930644 A1 WO 9930644A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
set forth
channel
piston
distal end
Prior art date
Application number
PCT/US1998/027099
Other languages
English (en)
Inventor
Joseph F. Paraschac
John A. Scholl
Thomas A. Silvestrini
Original Assignee
Keravision, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Keravision, Inc. filed Critical Keravision, Inc.
Priority to AU22018/99A priority Critical patent/AU2201899A/en
Publication of WO1999030644A1 publication Critical patent/WO1999030644A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • A61F2/148—Implantation instruments specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/013—Instruments for compensation of ocular refraction ; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/902—Method of implanting
    • Y10S623/905—Eye
    • Y10S623/906—Corneal

Definitions

  • This invention relates generally to opthalmosurgical devices, and more particularly to a device used for the introduction of a corneal implant into the cornea of a mammalian eye.
  • a corneal implant In general, such implants are used to adjust corneal curvature and correct vision abnormalities such as hyperopia. Anomalies in the overall shape of the eye can cause visual disorders. Hyperopia
  • farsightedness occurs when the front-to-back distance in the eyeball is too short. In such a case, parallel rays originating greater than 20 feet from the eye focus behind the retina. Although minor amounts of hyperopia can be resolved in the human eye by a muscular action known as "accommodation", aging often compromises the ability of the eye to adequately accommodate. In contrast, when the front-to-back distance of the eyeball is too long, myopia (“nearsightedness”) occurs and the focus of parallel rays entering the eye occurs in front of the retina.
  • Astigmatism is a condition which occurs when the parallel rays of light do not focus to a single point within the eye, but rather have a variable focus due to the fact that the cornea refracts light in a different meridian at different distances. Some degree of astigmatism is normal, but where it is pronounced, the astigmatism must be corrected.
  • Hyperopia, myopia, and astigmatism are usually corrected by glasses or contact lenses.
  • Surgical methods for the correction of such disorders are known. Such methods include radial keratotomy (see, e.g., U.S. Patents Nos. 4,815,463 and 4,688,570) and laser corneal ablation (see, e.g., U.S. Patent No. 4,941 ,093).
  • Another method for correcting these disorders is through the implantation of polymeric implants into the cornea instromal space to change the curvature of the cornea.
  • Devices currently available for introducing the implants into the eye include standard forceps which are used to grasp the implant and manipulate it into an incision formed in the eye.
  • the implant grasping surfaces of the forceps are typically flat or formed with small ridges, and do not conform to the specific shape of the implant. This makes it difficult to grasp the relatively small implants. Once the implant is picked up by the forceps, it is often difficult to retain the implant within the grasp of the forceps. If the implant is dropped it has to be sterilized again prior to use. These forceps are also not well suited for insertion of the implant into the incision.
  • the forceps are designed to grasp the implant only along its sides to allow the forceps to release and regrasp the implant, the implant often backs out of the forceps during insertion into the eye. This also makes it difficult to push and manipulate the implant once it is partially inserted into the incision.
  • these forceps are configured for holding, and introducing into the eye only one implant at a time. This requires reloading and repositioning of the forceps prior to inserting each implant into the eye. Since the forceps are not designed for storage of the implants, the implants cannot be preloaded and packaged with the forceps.
  • the present invention involves an instrument which facilitates simple and accurate introduction of corneal implants (or inserts) into an eye to adjust corneal curvature and correct vision abnormalities.
  • a device which is designed to facilitate single-handed operation.
  • a device of this invention is for use in introducing a corneal implant into a cornea of a human eye.
  • the device includes a body having a distal end and a proximal end, a guide portion disposed at the distal end and forming a channel, and a member coupled to the body.
  • the guide portion is configured for laterally supporting the implant when positioned in the channel and the member is arranged to axially support the implant when positioned in the channel.
  • a method of the present invention includes the steps of providing a corneal implant in a holder and axially forcing the implant into an incision formed in the cornea of the eye.
  • Fig. 1 is a schematic illustration of a horizontal section of an eye
  • Fig. 2 is a schematic illustration of an anterior portion of the eye showing various layers of the cornea
  • Figs. 3 A and 3B show respectively a front view and a cross-sectional view of a typical array of intracorneal implants inserted in an eye;
  • Fig. 4A is a plan view of a typical implant;
  • Fig. 4B is a cross-sectional view taken in the plane including line 4B— 4B of Fig. 4 A;
  • Fig. 5 is an elevational view of a device of the present invention for introducing the implant into an eye
  • Fig. 6 is a cross-sectional view taken in the plane including line 6—6 of Fig. 5;
  • Fig. 7 shows the device of Fig. 5 introducing the implant into an eye;
  • Fig. 8 is a cross-sectional view of the device of Fig. 5 with a threaded connection between a slide and a body of the device;
  • Fig. 9A is a cross-sectional view of the device of Fig. 5 with a locked connection between the slide and the body of the device;
  • Fig. 9B is an exploded view of the device of Fig. 9A;
  • Fig. 9C is a cross-sectional view of the device of Fig. 5 modified to include an implant separator for introducing multiple implants;
  • Figs. 9D-9G are schematic illustrations of a cartridge for use with the device of Fig. 5;
  • Fig. 10 is a plan view of a second embodiment of a device of the present invention
  • Fig. 10A is an enlarged fragmentary view of the device of Fig. 10;
  • Fig. 11 is a cross-sectional view taken in the plane including line 11—11 of Fig. 10 A;
  • Fig. 12 is a side view of the device of Fig. 10;
  • Fig. 13 is a side view of a third embodiment of a device of the present invention
  • Fig. 14 is a cross-sectional fragmentary view taken in the plane including line 14—
  • Fig. 15 is a schematic view showing the implant in an eye.
  • Corresponding reference characters indicate corresponding parts throughout the several views of the drawings.
  • Figure 1 shows a horizontal cross-section of the eye with the globe 11 of the eye resembling a sphere with an anterior bulged spherical portion representing the cornea 12.
  • the globe 11 of the eye consists of three concentric coverings enclosing the various transparent media through which the light must pass before reaching the light-sensitive retina 18.
  • the outermost covering is a fibrous protective portion the posterior, five-sixths of which is white and opaque and called the sclera 13, and sometimes referred to as the white of the eye where visible to the front.
  • the anterior one-sixth of this outer layer is the transparent cornea 12.
  • a middle covering is mainly vascular and nutritive in function and is made up of the choroid, ciliary body 16, and iris 17.
  • the choroid generally functions to maintain the retina 18.
  • the ciliary body 16 is involved in suspending the lens 21 and accommodation of the lens.
  • the iris 17 is the most anterior portion of the middle covering of the eye and is arranged in a frontal plane. It is a thin circular disc similar in function to the diaphragm of a camera, and is perforated near its center by a circular aperture called the pupil 19.
  • the size of the pupil varies to regulate the amount of light which reaches the retina 18. It contracts also by accommodation, which serves to sharpen the focus by diminishing spherical aberration.
  • the iris divides the space between the cornea 12 and the lens 21 into an anterior chamber 22 and the posterior chamber 23.
  • the innermost portion of covering is the retina 18, consisting of nerve elements which form the true receptive portion for visual impressions.
  • the retina 18 is a part of the brain arising as an outgrowth from the fore-brain, with the optic nerve 24 serving as a fiber tract connecting the retina part of the brain with the fore-brain.
  • a layer of rods and cones, lying just beneath a pigmented epithelium on the anterior wall of the retina serve as visual cells or photoreceptors which transform physical energy (light) into nerve impulses.
  • the vitreous body 26 is a transparent gelatinous mass which fills the posterior four- fifths of the globe 11. At its sides it supports the ciliary body 16 and the retina 18.
  • a frontal saucer-shaped depression houses the lens.
  • the lens 21 of the eye is a transparent bi-convex body of crystalline appearance placed between the iris 17 and vitreous body 26. Its axial diameter varies markedly with accommodation.
  • a ciliary zonule 27, consisting of transparent fibers passing between the ciliary body 16 and lens 21 serves to hold the lens 21 in position and enables the ciliary muscle to act on it.
  • this outermost fibrous transparent coating resembles a watch glass. Its curvature is somewhat greater than the rest of the globe and is ideally radially symmetric in nature. However, often it is more curved in one meridian than another giving rise to astigmatism. A central third of the cornea is called the optical zone with a slight flattening taking place outwardly thereof as the cornea thickens towards its periphery. Most of the refraction of the eye takes place through the cornea.
  • Figure 2 is a more detailed drawing of the anterior portion of the globe showing the various layers of the cornea 12 making up the epithelium 31. Epithelial cells on the surface thereof function to maintain transparency of the cornea 12. These epithelial cells are rich in glycogen, enzymes and acetylcholine and their activity regulates the corneal corpuscles and controls the transport of water and electrolytes through the lamellae of the stroma 32 of the cornea 12.
  • An anterior limiting lamella 33 is positioned between the epithelium 31 and the stroma 32 of the cornea.
  • the corneal stroma 32 is made up of lamellae having bands of fibrils parallel to each other and crossing the whole of the cornea. While most of the fibrous bands are parallel to the surface, some are oblique, especially anteriorly.
  • a posterior limiting lamella 34 is referred to as Descemet's membrane. It is a strong membrane sharply defined from the stroma 32 and resistant to pathological processes of the cornea.
  • the endothelium 36 is the most posterior layer of the cornea and consists of a single layer of cells.
  • the limbus 37 is the transition zone between the conjunctiva 38 and sclera on the one hand and the cornea 12 on the other.
  • the present invention relates to the introduction of an implant 40 into the cornea 12, typically and desirably between the lamellar layers making up the cornea, in a position meridional to the cornea to alleviate abnormalities such as hyperopia.
  • One or more of the implants 40 are typically inserted into the cornea 12 so that each subtends a portion of the meridian of the cornea outside of the cornea's central area, e.g., the area through which vision is achieved, but within the cornea's frontal diameter.
  • Figures 3 A and 3B show typical placement of the implants in the eye.
  • Figure 3 A is a frontal view of the cornea 12 of an eye having six implants 40 which are located within small meridional pockets 42.
  • a cross-sectional side view of the cornea 12 is shown in Fig. 3B.
  • FIGs 4A and 4B show one type of implant 40 which may be introduced into the eye by the devices of this invention.
  • the implants 40 are preferably formed from a relatively stiff, physiologically acceptable polymer, but may be formed from other materials, or may be formed from a hybrid of different materials.
  • the implant 40 has a central longitudinal axis A which may be arcuate or straight. As shown in Fig. 4B, the implant has a hexagonal shape as viewed in transverse cross section.
  • the implant 40 may have a width W of between 0.2 mm and 2.0 mm, a thickness T of between 0.15 mm and 0.5 mm, and a length L less than 3.0 mm, for example.
  • One or both of the ends of the implant 40 may also be tapered.
  • the device 50 comprises a body 52 having a distal end 54 and a proximal end 56, a guide portion 55 disposed at the distal end of the body and forming a channel 53, and a member coupled to the body.
  • the guide portion 55 of the body 52 is configured for laterally supporting the implant when positioned in the channel 53 and the member is arranged to axially support the implant when positioned in the channel.
  • the member comprises a drive member or piston 58 with the arrangement of the piston and implant 40 being such that as the piston moves in a distal direction (to the left as viewed in Fig.
  • the implant is urged along the channel 53 and into an incision formed in the corneal stroma, for introduction of the implant into the eye.
  • a slide 60 extends from the distal end of the body 52 to guide the implant 40 and provide a surface against which the implant may slide to facilitate smooth insertion of the implant into the incision, as further described below.
  • the body 52 is a generally tubular elongated member having an inside diameter slightly larger than the diameter of the piston 58 to allow for smooth axial movement of the piston.
  • the proximal end 56 of the body 52 may include a peripheral rim 64 for engagement by a surgeon's fingers to assist in actuation of the piston 58.
  • the body 52 may be formed from metal, a rigid polymer, or any other suitable material.
  • the piston 58 is in the form of a plunger similar in design to a plunger used in a syringe.
  • the piston 58 comprises a rod 66, preferably having a length greater than the length of the body.
  • a proximal end of the piston 58 has an enlarged portion 68 having a diameter greater than opening 70 in the proximal end 56 of the body 52 to limit the travel of the piston in the distal direction.
  • the piston 58 is preferably sized such that when the enlarged portion 68 of the piston is in contact with the rim 64 of the body 52, the end of the piston rod 66 extends past the distal end 54 of the body so that the piston can push the entire implant 40 onto a surface of the slide 60.
  • the piston 58 may be formed from metal, a stiff polymeric material or any other suitable material.
  • the slide 60 is located at the distal end 54 of the body 52 and is sized to fit within an incision 62 to guide the implant through the incision and into a pocket (or channel) 72 extending from the incision (Fig. 7).
  • the slide 60 extends from a forward side of the body
  • the slide 60 is preferably formed from a rigid material to compress corner 74 to allow the implant 40 to move easily past the corner.
  • the slide 60 may also be formed from a flexible material to allow the slide to bend around the corner 74.
  • the width W G of the slide 60 is preferably greater than the width W of the implant 40, and the length of the slide is preferably greater than the depth of the incision (Figs. 4B and 5).
  • the slide 60 may have configurations other than the one shown without departing from the scope of the invention.
  • the slide 60 may be straight for insertion into only the incision 62 rather than both the incision and the pocket 72.
  • the slide 60 may be permanently attached to the body 52 by soldering, adhesives or any other suitable means.
  • the slide 60 may also be removably connected to body 52 as described below.
  • the device 50 further includes a retaining member or ring 76 extending from the body 52 to the slide 60 to retain the implant 40 within the device prior to introducing the implant into the eye (Fig. 6).
  • the ring 76 comprises a first portion 78 which is generally cylindrical in shape and sized to fit over the distal end 54 of the body 52, and a second portion 80 having a generally tapered surface extending from the first portion to a distal end 82 of the ring.
  • the distal end 82 of the ring 76 has a width W R slightly larger than the width WQ of the slide 60 so that the ring may extend over the slide.
  • the ring 76 is formed from a resilient, expansible material which stretches to allow the implant 40 to pass through an opening 85 in the distal end 82 of the ring. As shown in Fig. 6, the opening 85 is sized so that the implant 40 must be pushed out from the ring 76 by the piston 58. As the piston 58 moves the implant 40 in the distal direction, the implant causes the opening 85 in the ring 76 to expand so that the insert can pass through. This design prevents the implant 40 from inadvertently falling out of the body 52 through the opening 85 in the ring
  • a ring 86 may also be sized to allow the implant 40 to pass freely therethrough without requiring the material of the ring to stretch (see Fig. 8).
  • the ring 76, 86 is preferably formed from a smooth material which is compatible with the eye to prevent damage to the cornea 12 if the ring contacts the cornea.
  • the ring 76, 86 may be configured for insertion into a portion of the incision 62, or may include a shoulder (not shown) for engagement with the cornea so that the device may rest on the cornea during introduction of the implant into the eye.
  • the distal end of the ring 76, 86 may also be beveled to prevent inadvertent contact with the cornea.
  • the retaining member may comprise a flap disposed on the distal end 54 of the body 52 to hold the implants in place within the device.
  • Figure 8 shows a slide 88 which is threadably connected to a body 89 for easy removal and replacement of the slide.
  • the slide 88 has a stem 90 extending from the end opposite the curved end of the slide.
  • the stem 90 is hollow and generally cylindrical in shape.
  • External threads 92 are formed on an outer surface of the stem 90.
  • the body 89 has internal threads 94 formed thereon for mating with the external threads 92 on the stem 90 of the slide 88.
  • a locking connection between a slide 96 and a body 98 is shown in Figs. 9A and
  • the body 98 includes a first locking element 100 for engagement with a second locking element 102 formed on a stem 104 of the slide 96.
  • the locking element 102 of the slide 96 snaps into the locking element 100 of the body 98.
  • Other types of locking or interengageable components may be used to removably connect the slide 96 to the body 98.
  • Figure 9C shows a modification of the body and piston of the device 50 of Fig. 5.
  • the inner diameter of a body 53 of the device has a groove 55 formed therein for receiving the implants 40.
  • a piston 57 includes an implant separator 59 at a distal end thereof for separating the implants 40 so that only one implant at a time is dispensed from the device.
  • the implant separator 59 is integrally formed with the piston rod 61 and is bent downward from a distal end of the piston rod.
  • the implant separator 59 engages one end of the implant 40 located at the distal end 63 of the body 53, and pushes the implant along the slide 60.
  • the piston 57 is then pulled in the proximal direction until the implant separator 59 engages the proximal end of the next implant.
  • the piston rod 61 may have markings on it to show how far to pull the piston 57 from the body 53 in order to engage the next implant 40.
  • the piston 57 is preferably stiff and may be formed from a cold worked stainless steel, nitinol, or any other suitable material.
  • a cartridge for use with the device 50 (Fig. 5) is schematically shown in Figs. 9D- 9G, and generally indicated at 65.
  • the cartridge 65 may be inserted into body 52 to replace the piston 57 of device 50.
  • the cartridge comprises a piston 67 slidable along a support 69, a lever 71 pivotally mounted on the support, a lever spring 73 for biasing the lever to a closed position, and a feeder spring 75.
  • the piston 67 has a longitudinal channel 77 formed on a bottom side thereof for storing the implants 40.
  • a pusher 79 extends from an upper side of the piston 67 and is used to push the implants 40 onto a guide surface 81 which is aligned with the slide 60 (shown in Fig. 5).
  • the piston 67 also includes a camming surface 91 for engagement with lever 71.
  • the lever 71 is pivotally connected to the support 69 by a pivot pin 83, and has an opening 85 for receiving a portion of the support upon which the lever slides in a generally radial direction.
  • the lever 71 is movable between a closed position (Fig. 9F) in which the implants 40 are retained within the channel 77, and an open position (Fig. 9E) in which an implant 40 may be moved from the channel onto an upper surface of the lever.
  • Operation of the cartridge 65 is as follows.
  • the implants 40 are placed on the support 69 and the piston 67 is positioned over the implants with the implants disposed within the channel 77 formed on the bottom side of the piston (Fig. 9D).
  • the lever 71 is in its normally closed position with the lever spring 73 forcing the lever against the piston 67.
  • the piston 67 is moved in a distal direction (to the left as viewed in Fig. 9E) and the camming surface 91 of the piston forces the lever downward into its open position.
  • the piston 67 is then moved in a proximal direction to allow the lever 71 to move back to its closed position and push the implant 40 upward (Fig. 9F).
  • the piston is next moved once again in the distal direction and the pusher 79 pushes the implant 40 onto the guide surface 81 and onto the slide 60 (Figs. 6 and 9G).
  • the implants 40 are constantly moved in the distal direction towards the lever by the feeder spring 75 which is connected to the support at 93.
  • the cartridge 65 may also be used alone without the body 52 and slide 60 of device 50.
  • the cartridge 65 may be loaded with the implants 40, and then sterilized and packaged, or the cartridge and implants may be inserted into the body 52 and sterilized and packaged as a complete device.
  • a second embodiment of the present invention is generally indicated at 110 and shown in Figs. 10-12.
  • the device 110 comprises a body 112, a guide portion 114, and a piston 116 axially slidable in the body.
  • the body 112 comprises a generally U-shaped member having two arms 118 extending generally parallel to a central longitudinal axis A 2 of the body, and forming a longitudinal slot 122 therebetween. End portions (or fingers) 120 of the arms 118 constitute the guide portion 114.
  • the arms 118 are movably biased towards one another and are movable in a direction generally transverse to the longitudinal axis A of the body 112.
  • a cam 124 is connected to the piston 116 and is axially slidable along the slot 122 to urge the arms 118 outward and spread the fingers 120.
  • Ramps 126 project from each arm into the slot 122 to provide camming surfaces for the cam 124.
  • the cam 124 is located in a position distal to the ramps 126 when the fingers are in a closed position. As the cam 124 is moved in a proximal direction (to the left as viewed in Fig.
  • the cam engages the ramps 126 and forces the arms 118 apart, thus causing the fingers 120 to move away from one another into an open position for loading the implants 40 into the device 110.
  • the cam 124 is moved in a distal direction, away from the ramps 126, the fingers 120 return to their closed position.
  • the arms 118 may be bent so that the cam 124 engages the arms directly to open fingers 120, thus eliminating the ramps 126.
  • the arms may also be formed as two separate pieces and attached to one another at their proximal ends.
  • Each finger 120 has a longitudinal groove 128 formed therein (Fig. 10A).
  • the grooves 128 define a channel having a transverse cross-sectional shape corresponding to the transverse cross-sectional shape of the implant 40 (Fig. 11).
  • the grooves 128 preferably have smooth surfaces to prevent damage to the implant as it moves through the channel.
  • the piston 116 is operable to push the implant 40 along the channel and into the incision as the piston moves in a distal direction.
  • a pusher 130 is disposed above the cam 124 and arranged for actuation by a surgeon's thumb for simple one handed operation.
  • the upper surface of the pusher 130 may be formed with ridges to increase the friction between the surgeon's thumb and the pusher for ease of operation.
  • the piston 116 may be configured for actuation by a surgeon's index finger rather than the surgeon's thumb.
  • the piston 116 may also be actuated by a rotary device (not shown) which causes axial movement of the piston to move the implant 40.
  • a slide 60 similar to the one shown in the first embodiment 50, may also be attached to the ends of the fingers
  • FIG. 13 A third embodiment of the present invention is shown in Fig. 13 and generally indicated at 140.
  • the device 140 has two grasping fingers 144 (defining the guide portion), movable towards one another for holding the implant 40.
  • the device has a stop (or flange) 142 to prevent the implant 40 from backing out from between the fingers 144.
  • the fingers 144 preferably have grooves 146 formed therein to define a channel having a transverse cross-sectional shape generally corresponding to the transverse cross-sectional shape of the implant (Fig. 14).
  • the stop 142 is attached to one side of one of the fingers
  • the stop 142 may also be integrally formed with one of the fingers 144. In addition to limiting longitudinal movement of the implant 40 relative to the channel, the stop 142 is also used to apply a direct axial force to one end of the implant 40 to assist in pushing the implant into the incision 62 and manipulating the implant into its proper position.
  • the device 140 may also have hinge operated fingers (not shown) similar to forceps available from Dutch Ophthalmic Research Center International (D.O.R.C.) of
  • the forceps include a sleeve which is axially movable in one direction to extend partially over the fingers and force the fingers into a closed position, and in the opposite direction to allow the fingers to spread apart.
  • a flexible hinge is fixedly connected to the sleeve and actuated by movement in the radial direction to cause axial movement of the sleeve. The hinge is normally biased to a position in which the fingers are spread apart.
  • a small incision 62 is first made in the outer periphery of the anterior surface of the cornea 12.
  • the implant 40 may be inserted into a single incision or through multiple incisions.
  • a small meridional incision is made in the outer periphery of the anterior surface of the cornea.
  • the incision may also be circumferential.
  • Figure 15 shows a small circumferential incision 150 and a meridional pocket 152 for placement of the implant.
  • the incision 150 is shown located within the cornea 12, but the incision may also be made outside of the cornea 12, within the limbus of the eye.
  • the pocket 152 is formed by inserting a blade of a pocket-forming device (not shown) through the incision 150 to separate stroma layers to form the pocket.
  • the blade creates a stromal delamination for receiving the implant.
  • the length, width and shape of the pocket are determined by the size and shape of the blade.
  • the implant 40 is then introduced through the incision and into the pocket 152.
  • a suitable positioning device may be used to properly position the implant 40 within the pocket.
  • the initial incision 150 may be closed by use of sutures, glue, staples, or by electrosurgical welding. It is to be understood that various other methods may be used to create the channels or pockets for the implants and other configurations or number of implants may be used without departing from the scope of the invention.
  • one or more implants 40 are first loaded into the device (Fig. 6).
  • the implant 40 is preferably loaded from the proximal end 56 of the body 52 by removing the piston 58 and placing the implants into the body lengthwise.
  • the implant 40 may also be loaded into the distal end 54 of the body 52 through the ring 76.
  • the device 50 is loaded, it is placed near the incision 62 and the slide 60 is inserted into the incision (Fig. 7).
  • the slide 60 is positioned adjacent to an upper edge 160 of the pocket 72.
  • the piston 58 is slowly actuated to advance the implant 40 into the incision 62, rearward of the slide 60.
  • the slide 60 prevents the implant 40 from getting caught on the corner 74 and allows for smooth insertion and positioning of the implant.
  • the slide 60 is removed from the incision 62. Multiple implants 40 may be inserted through the same incision 62.
  • the device 110 of the second embodiment is loaded axially from the open end of the fingers 120 (Fig. 10).
  • the pusher 130 is moved in the proximal direction until the cam 124 engages the ramps 126 extending from the arms 118.
  • the fingers 120 are now spread apart and the implant 40 may be loaded into the fingers.
  • the pusher 130 is then moved in the distal direction to close the fingers 120 to grasp the implant 40.
  • the device 110 is positioned over the incision and the pusher 130 is moved in the distal direction to introduce the implant 40 into the incision.
  • An implant 40 is inserted into the fingers 144 of the device 140 of the third embodiment in a method similar to the grasping of an implant with standard forceps, except that the implant is positioned with one end contiguous with the stop 142 (Fig. 13). The opposite end of the implant 40 is then inserted into the incision and the stop 142 prevents the implant from backing out from between the fingers 144. The stop 142 also helps to push the implant 40 into the incision and properly position the implant.
  • the devices may be sterilized using known procedures with sterilants such as ethylene oxide, radiation, or any other suitable sterilant.
  • the devices are preferably packaged in a sterilized condition.
  • the implants may be loaded into the devices and packaged with the device.
  • the implants may also be loaded into a cartridge which may be inserted into the device.
  • the device can then be reused by inserting a new cartridge.
  • the packaging may by dry and include an inert gas or contain a sterile fluid such as saline solution.
  • the devices of the present invention have numerous advantages over the prior art.
  • the devices provide for simple and accurate placement of the implants into the corneal stroma of the eye.
  • the design of the devices allows for single-handed operation by the surgeon and allows for the introduction of multiple implants into the eye at one time.
  • the implants may be loaded into the device and packaged with the device. All references cited herein are incorporated by reference.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Transplantation (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un dispositif permettant d'introduire un implant cornéen dans la cornée d'un oeil humain. Le dispositif comprend un corps, un élément couplé à ce dernier, et une partie guide. Le corps comprend une extrémité distale et une extrémité proximale. La partie guide, qui est placée à l'extrémité distale du corps, forme un canal. La partie guide est configurée pour supporter latéralement l'implant lorsque celui-ci est placé dans le canal et l'élément est disposé de façon qu'il supporte axialement l'implant lorsque celui-ci est placé dans le canal.
PCT/US1998/027099 1997-12-18 1998-12-18 Introducteur d'implant corneen WO1999030644A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU22018/99A AU2201899A (en) 1997-12-18 1998-12-18 Corneal implant introducer

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/993,594 1997-12-18
US08/993,594 US6050999A (en) 1997-12-18 1997-12-18 Corneal implant introducer and method of use

Publications (1)

Publication Number Publication Date
WO1999030644A1 true WO1999030644A1 (fr) 1999-06-24

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US (1) US6050999A (fr)
AU (1) AU2201899A (fr)
WO (1) WO1999030644A1 (fr)

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US6358261B1 (en) 1999-11-05 2002-03-19 Alcon Universal Ltd. Lamellar dissecting instrument
US6358262B1 (en) 1999-11-05 2002-03-19 Alcon Universal Ltd. Lamellar dissecting instrument
WO2001085065A1 (fr) * 2000-05-06 2001-11-15 Duckworth & Kent Limited Injecteur ophtalmologique
GB2369301A (en) * 2000-05-06 2002-05-29 Duckworth & Kent Ltd Ophthalmic injector
GB2369301B (en) * 2000-05-06 2004-03-03 Duckworth & Kent Ltd Ophthalmic injector
US9987472B2 (en) 2001-04-07 2018-06-05 Glaukos Corporation Ocular implant delivery systems
US9572963B2 (en) 2001-04-07 2017-02-21 Glaukos Corporation Ocular disorder treatment methods and systems
WO2004010876A1 (fr) * 2002-06-28 2004-02-05 3062696 Nova Scotia Limited Dispositif de dilatation de pupille et appareil d'utilisation associe
AU2004264913B2 (en) * 2003-08-05 2011-08-25 Glaukos Corporation Devices and methods for glaucoma treatment
JP2013009982A (ja) * 2003-08-05 2013-01-17 Glaukos Corp 緑内障治療装置
JP2014193366A (ja) * 2003-08-05 2014-10-09 Glaukos Corp 緑内障治療装置
AU2011253668B2 (en) * 2003-08-05 2015-11-05 Glaukos Corporation Devices and methods for glaucoma treatment
EP2351589A1 (fr) * 2003-08-05 2011-08-03 Glaukos Corporation Dispositifs de traitement du glaucome
JP2007501066A (ja) * 2003-08-05 2007-01-25 グローコス コーポレーション 緑内障治療装置および方法
US9962290B2 (en) 2006-11-10 2018-05-08 Glaukos Corporation Uveoscleral shunt and methods for implanting same
US10828195B2 (en) 2006-11-10 2020-11-10 Glaukos Corporation Uveoscleral shunt and methods for implanting same
US9554940B2 (en) 2012-03-26 2017-01-31 Glaukos Corporation System and method for delivering multiple ocular implants
US9592151B2 (en) 2013-03-15 2017-03-14 Glaukos Corporation Systems and methods for delivering an ocular implant to the suprachoroidal space within an eye
EP3492052A1 (fr) * 2017-11-29 2019-06-05 Roberto Gustavo Albertazzi Injecteur et segment intracornéen pour traiter des troubles de la cornée

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